COLLEGIUM PHARMACEUTICAL, INC - Quarter Report: 2015 June (Form 10-Q)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 2015
OR
o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to
Commission file number: 001-37372
Collegium Pharmaceutical, Inc.
(Exact name of registrant as specified in its charter)
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Virginia |
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03-0416362 |
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780 Dedham Street, Suite 800 |
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02021 |
(781) 713-3699
(Registrant’s telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No o
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes x No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
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Large accelerated filero |
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Accelerated filer o |
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Non-accelerated filer x |
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Smaller reporting company o |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No x
As of July 31, 2015 there were 20,687,829 shares of Common Stock, $0.001 par value per share, outstanding.
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4 | ||
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Management’s Discussion and Analysis of Financial Condition and Results of Operations |
12 | |
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15 | ||
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FORWARD-LOOKING STATEMENTS
Statements made in this Quarterly Report that are not statements of historical or current facts, such as those under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements discuss our current expectations and projections relating to our financial condition, results of operations, plans, objectives, future performance and business. These statements may be preceded by, followed by or include the words “aim,” “anticipate,” “believe,” “estimate,” “expect,” “forecast,” “intend,” “outlook,” “plan,” “potential,” “project,” “projection,” “seek,” “may,” “could,” “would,” “will,” “should,” “can,” “can have,” “likely,” the negatives thereof and other words and terms of similar meaning.
Forward-looking statements are inherently subject to risks, uncertainties and assumptions; they are not guarantees of performance. You should not place undue reliance on these statements. We have based these forward-looking statements on our current expectations and projections about future events. Although we believe that our assumptions made in connection with the forward-looking statements are reasonable, we cannot assure you that the assumptions and expectations will prove to be correct.
You should understand that the following important factors could affect our future results and could cause those results or other outcomes to differ materially from those expressed or implied in our forward-looking statements:
· our ability to obtain and maintain regulatory approval of our product candidates, and any related restrictions, limitations, and/or warnings in the label of an approved product candidate;
· our plans to commercialize our product candidates;
· the size and growth potential of the markets for our product candidates, and our ability to service those markets;
· our ability to develop sales and marketing capabilities, whether alone or with potential future collaborators;
· the rate and degree of market acceptance of our product candidates;
· the outcome of any patent infringement or other litigation that may be brought against us, including litigation with Purdue Pharma, L.P.;
· our ability to attract collaborators with development, regulatory and commercialization expertise;
· the success, cost and timing of our product development activities, studies and clinical trials;
· our ability to obtain funding for our operations;
· regulatory developments in the United States and foreign countries;
· our expectations regarding our ability to obtain and adequately maintain sufficient intellectual property protection for our product candidates;
· our ability to operate our business without infringing the intellectual property rights of others;
· the performance of our third-party suppliers and manufacturers;
· the success of competing products that are or become available;
· the loss of key scientific or management personnel;
· our expectations regarding the period during which we qualify as an emerging growth company under the JOBS Act; and
· the accuracy of our estimates regarding expenses, future revenue, capital requirements and need for additional financing.
In light of these risks and uncertainties, expected results or other anticipated events or circumstances discussed in this Form 10-Q (including the exhibits hereto) might not occur. We undertake no obligation, and specifically decline any obligation, to publicly update or revise any forward-looking statements, even if experience or future developments make it clear that projected results expressed or implied in such statements will not be realized, except as may be required by law.
See the section entitled “Risk Factors” in our Current Report on Form 8-K, filed with the United States Securities and Exchange Commission (the “SEC”) on June 19, 2015 for a more complete discussion of these risks and uncertainties and for other risks and uncertainties. Those factors and the other risk factors described therein are not necessarily all of the important factors that could cause actual results or developments to differ materially from those expressed in any of our forward-looking statements. Other unknown or unpredictable factors also could harm our results. Consequently, there can be no assurance that actual results or developments anticipated by us will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, us. Given these uncertainties, prospective investors are cautioned not to place undue reliance on such forward-looking statements.
Item 1. Condensed Financial Statements (Unaudited).
Collegium Pharmaceutical, Inc.
(unaudited)
(in thousands, except share and per share amounts)
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June 30, |
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December 31, |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
112,413 |
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$ |
1,634 |
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Refundable PDUFA fee |
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— |
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2,335 |
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Prepaid expenses and other current assets |
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1,219 |
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527 |
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Total current assets |
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113,632 |
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4,496 |
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Property and equipment, net |
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445 |
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514 |
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Restricted cash |
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97 |
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80 |
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Total assets |
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$ |
114,174 |
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$ |
5,090 |
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Liabilities, convertible redeemable preferred stock and shareholders’ deficit |
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Current liabilities: |
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Accounts payable |
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$ |
2,239 |
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$ |
2,208 |
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Accrued expenses |
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1,671 |
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1,956 |
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Current portion of deferred rent and lease note payable |
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30 |
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59 |
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Current portion of term loan payable |
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2,250 |
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1,194 |
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Convertible bridge notes with related parties |
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— |
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5,000 |
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Total current liabilities |
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6,190 |
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10,417 |
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Lease incentive obligation |
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85 |
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101 |
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Term loan payable, long-term |
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5,480 |
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6,813 |
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Total liabilities |
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11,755 |
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17,331 |
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Commitments and contingencies (See note 8) |
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Series A convertible redeemable preferred stock, $0.001 par value; authorized shares — none at June 30, 2015 and 18,498,419 at December 31, 2014; issued and outstanding shares — none at June 30, 2015 and 9,232,334 at December 31, 2014; liquidation preference of none at June 30, 2015 and $12,781 at December 31, 2014 |
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— |
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12,781 |
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Series B convertible redeemable preferred stock, $0.001 par value; authorized shares — none at June 30, 2015 and 27,324,237 at December 31, 2014; issued and outstanding shares — none at June 30, 2015 and 27,324,237 at December 31, 2014; liquidation preference of none at June 30, 2015 and $51,212 at December 31, 2014 |
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— |
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51,212 |
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Series C convertible redeemable preferred stock, $0.001 par value; authorized shares — none at June 30, 2015 and 8,658,344 at December 31, 2014; issued and outstanding shares — none at June 30, 2015 and 8,658,008 at December 31, 2014; liquidation preference of none at June 30, 2015 and $13,114 at December 31, 2014 |
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— |
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13,114 |
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Series D convertible redeemable preferred stock, $0.001 par value; authorized shares — none at June 30, 2015 and December 31, 2014; issued and outstanding shares — none at June 30, 2015 and December 31, 2014; liquidation preference of none at June 30, 2015 and December 31, 2014 |
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— |
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— |
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Shareholders’ equity (deficit): |
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Common stock, $0.001 par value; authorized shares — 113,000,000 at June 30, 2015 and 72,000,000 at December 31, 2014; issued and outstanding shares — 20,687,787 at June 30, 2015 and 1,006,219 at December 31, 2014 |
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20 |
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1 |
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Additional paid-in capital |
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212,523 |
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12,407 |
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Accumulated deficit |
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(110,121 |
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(101,753 |
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Treasury stock |
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(3 |
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(3 |
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Total shareholders’ equity (deficit) |
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102,419 |
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(89,348 |
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Total liabilities, convertible redeemable preferred stock and shareholders’ equity (deficit) |
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$ |
114,174 |
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$ |
5,090 |
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See accompanying notes to the unaudited condensed financial statements.
Collegium Pharmaceutical, Inc.
CONDENSED STATEMENTS OF OPERATIONS
(unaudited)
(in thousands, except share and per share amounts)
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Three months ended, |
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Six months ended |
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2015 |
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2014 |
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2015 |
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2014 |
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Operating expenses: |
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Research and development |
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$ |
1,641 |
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$ |
3,565 |
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$ |
3,086 |
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$ |
6,834 |
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General and administrative |
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2,934 |
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523 |
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5,120 |
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999 |
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Total operating expenses |
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4,575 |
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4,088 |
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8,206 |
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7,833 |
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Loss from operations |
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(4,575 |
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(4,088 |
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(8,206 |
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(7,833 |
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Other expense: |
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Interest expense, net |
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99 |
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29 |
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254 |
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59 |
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Gain on extinguishment |
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— |
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— |
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(91 |
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— |
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Total other expense, net |
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99 |
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29 |
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163 |
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59 |
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Net loss |
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$ |
(4,674 |
) |
$ |
(4,117 |
) |
$ |
(8,369 |
) |
$ |
(7,892 |
) |
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Net loss per share—basic and diluted |
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$ |
(0.45 |
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$ |
(5.33 |
) |
$ |
(0.18 |
) |
$ |
(10.36 |
) |
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Weighted-average number of common shares used in net loss per share-basic and diluted |
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11,791,546 |
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926,239 |
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6,426,431 |
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919,465 |
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See accompanying notes to the unaudited condensed financial statements.
Collegium Pharmaceutical, Inc.
CONDENSED STATEMENTS OF CASH FLOWS
(unaudited)
(in thousands)
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Six months ended |
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2015 |
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2014 |
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Operating activities |
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Net loss |
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$ |
(8,369 |
) |
$ |
(7,892 |
) |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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92 |
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95 |
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Lease incentive |
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(16 |
) |
(17 |
) | ||
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Stock-based compensation expense |
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714 |
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11 |
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Non-cash interest expense |
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7 |
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4 |
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Accrual of back end fees related to note payable |
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— |
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(14 |
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Changes in operating assets and liabilities: |
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Prepaid expenses and other current assets |
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(692 |
) |
18 |
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Refundable PDUFA fee |
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2,335 |
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— |
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Accounts payable |
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32 |
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1,012 |
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Accrued expenses |
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(195 |
) |
811 |
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Net cash used in operating activities |
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(6,092 |
) |
(5,972 |
) | ||
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Investing activities |
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Purchases of property and equipment |
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(23 |
) |
— |
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Net cash used in investing activities |
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(23 |
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— |
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Financing activities |
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Proceeds from issuance of common stock, net of issuance costs of $2,408 |
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72,029 |
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— |
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Proceeds from issuance of Series D convertible redeemable preferred stock, net of issuance costs of $193 |
|
44,807 |
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— |
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(Repayment of) borrowing from term note |
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(368 |
) |
1,044 |
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Repayment of lease note payable |
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(29 |
) |
(31 |
) | ||
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Restricted cash |
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(16 |
) |
— |
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Proceeds from the exercise of stock options |
|
471 |
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1 |
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Net cash provided by financing activities |
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116,894 |
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1,014 |
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Net increase (decrease) in cash and cash equivalents |
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110,779 |
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(4,958 |
) | ||
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Cash and cash equivalents at beginning of period |
|
1,634 |
|
7,551 |
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Cash and cash equivalents at end of period |
|
$ |
112,413 |
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$ |
2,593 |
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Supplemental disclosure of non-cash activities |
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|
|
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Preferred stock conversion to common stock |
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$ |
120,302 |
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$ |
— |
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Accruals of dividends and accretion to redemption value |
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$ |
24,572 |
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$ |
1,637 |
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Conversion of bridge note to preferred stock |
|
$ |
5,000 |
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$ |
— |
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|
Cash paid for interest |
|
$ |
202 |
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$ |
46 |
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Cash paid for taxes |
|
$ |
2 |
|
$ |
— |
|
|
Repayment of term note with proceeds of note payable |
|
$ |
— |
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$ |
944 |
|
See accompanying notes to the unaudited condensed financial statements.
Collegium Pharmaceutical, Inc.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(unaudited, in thousands, except share and per share amounts)
1. Nature of Business
Collegium Pharmaceutical, Inc. (the “Company”) was incorporated in Delaware in April 2002 and then reincorporated in Virginia in July 2014. The Company has its principal operations in Canton, Massachusetts. The Company is a specialty pharmaceutical company developing and planning to commercialize next-generation abuse-deterrent products that incorporate the Company’s patented DETERx® platform technology for the treatment of chronic pain and other diseases. The Company’s lead product candidate, Xtampza ERTM, or Xtampza, is an abuse-deterrent, extended-release, oral formulation of oxycodone, a widely prescribed opioid medication. Xtampza has received Fast Track status from the U.S. Food and Drug Administration (“FDA”). The Company’s new drug application (“NDA”) filing for Xtampza was accepted by the FDA on February 10, 2015. On February 25, 2015, the FDA set a Prescription Drug User Fee Act, or PDUFA, goal date of October 12, 2015 for completion of its review of the Xtampza NDA.
The Company’s operations are subject to certain risks and uncertainties. The principal risks include negative outcome of clinical trials, inability or delay in completing clinical trials or obtaining regulatory approvals, changing market conditions for products being developed by the Company, the need to retain key personnel and protect intellectual property, patent infringement litigation and the availability of additional capital financing on terms acceptable to the Company.
2. Summary of Significant Accounting Policies
Basis of presentation
The accompanying unaudited condensed financial statements of Collegium Pharmaceutical, Inc. (“the Company”) have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial reporting and as required by Regulation S-X, Rule 10-01. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, all adjustments (including those which are normal and recurring) considered necessary for a fair presentation of the interim financial information have been included. When preparing financial statements in conformity with GAAP, the Company must make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, expenses and related disclosures at the date of the financial statements. Actual results could differ from those estimates. Additionally, operating results for the three months ended June 30, 2015 are not necessarily indicative of the results that may be expected for any other interim period or for the fiscal year ending December 31, 2015. The condensed interim financial statements should be read in conjunction with the audited financial statements and notes thereto included in the Company’s Prospectus dated May 6, 2015 (“Prospectus”) filed pursuant to Rule 424(b)(4) under the Securities Act of 1933, as amended, with the Securities and Exchange Commission (“SEC”) on May 7, 2015 in conjunction with the Company’s initial public offering of common stock.
Initial Public Offering
In May 2015, the Company closed an initial public offering (“IPO”) of its common stock, which resulted in the sale of 6,670,000 shares of its common stock at a public offering price of $12.00 per share, including 870,000 shares of common stock upon the exercise by the underwriters of their option to purchase additional shares at the public offering price. The Company received proceeds from the IPO of approximately $72.0 million, after deducting underwriting discounts, commissions and expenses payable by the Company.
In connection with preparing for the IPO, the Company’s Board of Directors and shareholders approved a one-for-6.9 reverse stock split of the Company’s common stock. The reverse stock split became effective in April 2015. All share and per share amounts in the condensed interim financial statements and notes thereto have been retroactively adjusted for all periods presented to give effect to this reverse stock split, including reclassifying an amount equal to the reduction in par value of common stock to additional paid-in capital. In connection with the closing of the IPO, all of the Company’s outstanding convertible preferred stock automatically converted to common stock in May 2015, resulting in an additional 12,591,456 shares of common stock of the Company becoming outstanding. The significant increase in common stock outstanding in May 2015 is expected to impact the year-over-year comparability of the Company’s net loss per share calculations in future periods.
Subsequent Events
The Company considers events or transactions that occur after the balance sheet date but prior to the issuance of the financial statements to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure. Through the date of the filing of this Form 10-Q, the Company has concluded that no subsequent events have occured that require disclosure, except as described in Note 9.
Critical Accounting Policies
Earnings (Loss) per Common Share
Earnings (loss) per common share is calculated using the two-class method, which is an earnings allocation formula that determines earnings (loss) per share for the holders of the Company’s common shares and participating securities. All series of preferred stock contain participation rights in any dividend paid by the Company and are deemed to be participating securities. Earnings available to common shareholders and participating convertible redeemable preferred shares is allocated first to the preferred stock based upon the distribution criteria in the Company’s Articles of Incorporation then the remainder to the common shareholders. The participating securities do not include a contractual obligation to share in losses of the Company and are not included in the calculation of net loss per share in the periods that have a net loss.
Diluted earnings per share is computed using the more dilutive of (a) the two-class method, or (b) the if-converted method. The Company allocates earnings first to preferred shareholders based on dividend rights and then to common and preferred shareholders based on ownership interests. The weighted-average number of common shares included in the computation of diluted earnings (loss) gives effect to all potentially dilutive common equivalent shares, including outstanding stock options, warrants, convertible redeemable preferred stock and the potential issuance of stock upon the conversion of the Company’s convertible notes. Common stock equivalent shares are excluded from the computation of diluted earnings (loss) per share if their effect is antidilutive.
Recent Accounting Pronouncements
Revenue Recognition
In May 2014, the Financial Accounting Standards Board (“FASB”), issued Accounting Standards Update (“ASU”), No. 2014-09, which amends the guidance for accounting for revenue from contracts with customers. This ASU supersedes the revenue recognition requirements in Accounting Standards Codification (“ASC”), Topic 605, Revenue Recognition , and creates a new Topic 606, Revenue from Contracts with Customers. Two adoption methods are permitted: retrospectively to all prior reporting periods presented, with certain practical expedients permitted; or retrospectively with the cumulative effect of initially adopting the ASU recognized at the date of initial application. On July 9, 2015, the FASB approved a deferral of the effective date by one year to December 15, 2017 for annual reporting periods beginning after that date. The FASB also approved permitting early adoption of the standard, but not before the original effective date of December 15, 2016. The Company has not yet determined which adoption method it will utilize or the effect that the adoption of this guidance will have on its financial statements.
3. Net Loss per Common Share
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Three months ended, |
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Six months ended |
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|
|
2015 |
|
2014 |
|
2015 |
|
2014 |
| ||||
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Net loss |
|
$ |
(4,674 |
) |
$ |
(4,117 |
) |
$ |
(8,369 |
) |
$ |
(7,892 |
) |
|
Extinguishment of preferred stock - see note 7 |
|
— |
|
— |
|
31,806 |
|
— |
| ||||
|
Accretion of prior preferred stock - see note 7
|
|
|
|
(823 |
) |
(23,327 |
) |
(1,637 |
) | ||||
|
Accretion and dividends of series D preferred stock |
|
(641 |
) |
— |
|
(1,245 |
) |
— |
| ||||
|
Loss attributable to common shareholders—basic and diluted |
|
$ |
(5,315 |
) |
$ |
(4,940 |
) |
$ |
(1,135 |
) |
$ |
(9,529 |
) |
|
Weighted-average number of common shares used in net loss per share-basic and diluted |
|
11,791,546 |
|
926,239 |
|
6,426,431 |
|
919,465 |
| ||||
|
Net loss per share-basic and diluted |
|
$ |
(0.45 |
) |
$ |
(5.33 |
) |
$ |
(0.18 |
) |
$ |
(10.36 |
) |
The following potentially dilutive securities, which represent all outstanding potentially dilutive securities, were excluded from the calculation of diluted net loss per share due to their anti-dilutive effect (in common stock equivalent shares):
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|
|
Three months |
|
Six months ended June 30, |
| ||||
|
|
|
2015 |
|
2014 |
|
2015 |
|
2014 |
|
|
Outstanding stock options |
|
1,086,789 |
|
315,389 |
|
1,086,789 |
|
315,389 |
|
|
Warrants |
|
2,445 |
|
6,262 |
|
2,445 |
|
6,262 |
|
|
Redeemable convertible preferred stock |
|
— |
|
6,552,820 |
|
— |
|
6,552,820 |
|
|
Unvested restricted stock |
|
164,539 |
|
41,684 |
|
164,539 |
|
41,684 |
|
4. Fair Value of Financial Instruments
The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. The fair value hierarchy is now established that prioritizes valuation inputs based on the observable nature of those inputs. The fair value hierarchy applies only to the valuation inputs used in determining the reported fair value of the investments and is not a measure of the investment credit quality. The hierarchy defines three levels of valuation inputs:
|
Level 1 inputs |
Quoted prices in active markets for identical assets or liabilities |
|
Level 2 inputs |
Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly |
|
Level 3 inputs |
Unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability |
The following tables present the Company’s financial instruments carried at fair value using the lowest level input applicable to each financial instrument at June 30, 2015 and December 31, 2014.
|
Description |
|
Total |
|
Quoted prices |
|
Significant |
|
Significant |
| ||||
|
June 30 2015 |
|
|
|
|
|
|
|
|
| ||||
|
Money market funds, included in cash equivalents |
|
$ |
104,911 |
|
$ |
104,911 |
|
$ |
— |
|
$ |
— |
|
|
|
|
|
|
|
|
|
|
|
| ||||
|
December 31, 2014 |
|
|
|
|
|
|
|
|
| ||||
|
Money market funds, included in cash equivalents |
|
$ |
457 |
|
$ |
457 |
|
$ |
— |
|
$ |
— |
|
The Company’s cash equivalents are comprised of money market funds that are measured on a recurring basis based on quoted market prices.
5. Accrued Expenses
Accrued expenses consisted of the following:
|
|
|
June 30, 2015 |
|
December |
| ||
|
Accrued compensation |
|
$ |
725 |
|
$ |
635 |
|
|
Accrued development costs |
|
647 |
|
970 |
| ||
|
Accrued audit and legal |
|
145 |
|
249 |
| ||
|
Accrued interest |
|
32 |
|
71 |
| ||
|
Accrued other |
|
122 |
|
31 |
| ||
|
Total accrued expenses |
|
$ |
1,671 |
|
$ |
1,956 |
|
6. Convertible Bridge Note with Related Party
In November and December 2014 the Company entered into a Note Purchase Agreement (the “Bridge Notes”) allowing for the issuance of $5,000 of convertible promissory notes to a group of investors (the “Holders”) bearing interest at a rate per annum of 6.0%. The Holders are related parties of the Company. In connection with the Series D convertible preferred stock financing (see note 7), the Bridge Notes converted into Series D convertible preferred stock. Upon the conversion, the Company recognized a gain on extinguishment of $91.
7. Convertible Preferred Stock
In March 2015, the Company issued and sold an aggregate of 41,666,667 shares of Series D convertible preferred stock for aggregate consideration of $50,000, comprised of $45,000 in cash and conversion of $5,000 in Bridge Notes. The accrued interest on the convertible notes was waived.
Concurrently with the issuance of the Series D Preferred Stock, the Company amended and restated its Articles of Incorporation (the “Amended Articles”). The Company made certain amendments to the terms of the Series A, Series B and Series C Preferred Stock (together, the “Prior Preferred Stock”). Prior to the Amended Articles the Series A, Series B and Series C accrued dividends at a rate of 4.5%, 8.0% and 8.0% per annum, respectively, per share. All accrued and unpaid dividends on the Prior Preferred Stock were automatically cancelled and forfeited and the Prior Preferred Stock no longer accrued dividends. Prior to the cancellation and forfeiture of accrued dividends, the Prior Preferred Stock had accrued dividends of $622 during 2015. The holders of outstanding shares of Prior Preferred Stock were entitled to receive dividends, when, as and if declared by the Board of Directors. The mandatory conversion for all series of Prior Preferred Stock was modified so as to occur upon an initial public offering with gross proceeds in excess of $50,000. The amendments to the Prior Preferred Stock were treated as an extinguishment which resulted in a gain on extinguishment of $31,806. The gain on extinguishment was added to net loss to arrive at income available to common shareholders in the calculation of earnings per share. During the six months and three months ended June 30, 2015, total accrued dividends and accretion for preferred stock was $1,245 and $641, respectively.
In connection with the closing of the IPO, all of the Company’s outstanding convertible preferred stock automatically converted to common stock in May 2015, resulting in an additional 12,591,456 shares of common stock of the Company becoming outstanding.
8. Stock-based Compensation
In July 2014, the Company adopted the 2014 Stock Incentive Plan (the “Plan”), under which 525,700 shares of common stock are authorized for issuance to employees, officers, directors, consultants and advisors of the Company. In connection with the Company’s reincorporation into Virginia in July 2014, each outstanding option to purchase shares of common stock under the Company’s 2012 Stock Incentive Plan and 2002 Stock Plan, was automatically terminated and replaced with an option to purchase shares of common stock under the Plan having the same vesting terms and exercise price as the option that was replaced. The Plan provides for granting of both Internal Revenue Service qualified incentive stock options (“ISOs”) and non-qualified options (“NQs”), restricted stock awards (“RSAs”) and restricted stock units (“RSUs”). Stock options generally vest over a four year period of service; however, certain options contain performance conditions. The options generally have a ten year contractual life and, upon termination, vested options are generally exercisable between one and three months following the termination date, while unvested options are forfeited immediately.
In April 2015, the Plan was amended to increase the maximum number of shares of common stock that may be issued to 2,700,000 shares. In addition, an “evergreen provision” was added to the Plan that allows for an annual increase in the number of shares of common stock available for issuance under the Plan. The annual increase will be added on the first day of each fiscal year beginning with the fiscal year ending December 31, 2016, and on each anniversary thereof until the expiration of the Plan equal to 4% of the outstanding shares of our common stock on December 31st of the immediately preceding fiscal year (or such lesser number of shares of common stock as determined by the board of directors).
Restricted common stock
A summary of the Company’s restricted stock activity for the six months ended June 30, 2015 and related information is as follows:
|
|
|
Shares |
|
Weighted- |
| |
|
Unvested at December 31, 2014 |
|
15,387 |
|
$ |
0.69 |
|
|
Granted |
|
194,694 |
|
5.73 |
| |
|
Vested |
|
(118,005 |
) |
5.19 |
| |
|
Unvested at June 30, 2015 (1) |
|
92,076 |
|
$ |
5.57 |
|
(1) Excludes 72,463 shares of unvested restricted stock remaining from the early exercise of stock options as of June 30, 2015.
Stock options
A summary of the Company’s stock option activity and related information follows:
|
|
|
Shares |
|
Weighted- |
|
Weighted- |
|
Aggregate |
| ||
|
Outstanding at December 31, 2014 |
|
281,029 |
|
$ |
0.69 |
|
|
|
|
| |
|
Granted |
|
927,452 |
|
8.51 |
|
|
|
|
| ||
|
Exercised |
|
(121,692 |
) |
3.89 |
|
|
|
|
| ||
|
Canceled |
|
— |
|
— |
|
|
|
|
| ||
|
Outstanding at June 30, 2015 |
|
1,086,789 |
|
$ |
7.01 |
|
9.3 |
|
$ |
11,765 |
|
|
Exercisable at June 30, 2015 |
|
167,639 |
|
$ |
2.29 |
|
7.8 |
|
$ |
2,606 |
|
|
Vested and expected to vest at June 30, 2015 |
|
1,065,883 |
|
$ |
7.13 |
|
9.4 |
|
$ |
12,294 |
|
The fair value of each stock option is estimated on the grant date using the Black-Scholes option-pricing model using the following assumptions:
|
|
|
Six months ended |
| ||
|
|
|
2015 |
|
2014 |
|
|
Risk-free interest rate |
|
1.7 |
% |
1.8 |
% |
|
Dividend yield |
|
— |
|
— |
|
|
Volatility |
|
77 |
% |
77 |
% |
|
Expected term (years) |
|
6.25 |
|
6.25 |
|
9. Commitments and Contingencies
The Company’s NDA filing for Xtampza is a 505(b)(2) application, which allows the Company to reference data from an approved drug listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the ‘‘Orange Book’’), in this case OxyContin OP. In connection with the 505(b)(2) process, the Company certified to the FDA and notified Purdue Pharma, L.P. (‘‘Purdue’’), as the holder of the NDA and any other Orange Book-listed patent owners, that the Company does not infringe any of the patents listed for OxyContin OP in the Orange Book. Under the Hatch-Waxman Act of 1984 (the ‘‘Hatch-Waxman Act’’), Purdue can elect to sue the Company for infringement, and if they do, receive a stay of up to 30 months before the FDA can issue a final approval for Xtampza, unless the stay is earlier terminated. On March 24, 2015, Purdue sued the Company in the District of Delaware asserting infringement of four patents. On March 26, 2015, Purdue filed a second suit against the Company in the District of Massachusetts asserting infringement of the same four patents. On July 23, 2015, Purdue voluntarily dismissed the Massachusetts suit. On August 6, 2015, the Delaware court dismissed the suit in Delaware and issued a memorandum opinion finding the Delaware court lacks personal jurisdiction over the Company Following the dismissal in Delaware, on August 6, 2015, the Company filed a complaint in the Southern District of New York asserting an action to obtain patent certainty, and requesting that the New York court find that Xtampza will not infringe any valid patent claim of the patents asserted by Purdue in the Delaware action. Also on August 6, 2015, Purdue sued the Company in the District of Massachusetts asserting the same claims as the prior suit. On August 7, 2015, Purdue filed a motion in the Delaware court requesting reconsideration of the August 6, 2015 order that dismissed the case. In the motion requesting reconsideration, Purdue asks that the Delaware court find that it does have personal jurisdiction over the Company and then transfer the case to the District of Massachusetts. At this time the Company is unable to provide meaningful quantification of how this potential litigation may impact its future financial condition, results of operations, or cash flows.
In March 2015, the Company amended its lease to include an additional 9,660 square feet of space for a total of 19,335 square feet. In addition, the lease term was extended and now terminates on the date that is 5 years following the date, which has not yet been determined, on which the landlord delivers the expansion space with certain improvements substantially completed. At the Company’s election, the lease term may be extended for an additional 5-year term.
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and related notes appearing elsewhere in this quarterly report. The following discussion contains forward-looking statements that involve risks uncertainties and assumptions. Our actual results and the timing of certain events could differ materially from those anticipated in these forward-looking statements as a result of many factors. We discuss factors that we believe could cause or contribute to these differences below and elsewhere in this quarterly report, including those set forth under “Forward-looking Statements” and “Risk Factors”, and under the heading “Risk Factors” in the Company’s Current Report on Form 8-K filed with the SEC on June 19, 2015.
OVERVIEW
We are a specialty pharmaceutical company developing and planning to commercialize next-generation abuse-deterrent products that incorporate our patented DETERx platform technology for the treatment of chronic pain and other diseases. Our lead product candidate, Xtampza, is an abuse-deterrent, extended-release, oral formulation of oxycodone, a widely prescribed opioid medication. Xtampza has received Fast Track status from the U.S. Food and Drug Administration, or FDA. Our new drug application, or NDA, filing for Xtampza was accepted by the FDA on February 10, 2015. On February 25, 2015, the FDA set a Prescription Drug User Fee Act, or PDUFA, goal date of October 12, 2015 for completion of its review of the Xtampza NDA.
Xtampza has the same active ingredient as OxyContin OP, which is the largest selling abuse-deterrent, extended-release opioid in the United States by dollars, with $2.5 billion in U.S. sales in 2014. We conducted a comprehensive preclinical and clinical program for Xtampza consistent with FDA guidance on abuse-deterrence. These studies and clinical trials demonstrated that chewing, crushing and/or dissolving Xtampza, and then taking it orally or smoking, snorting, or injecting it did not meaningfully change its drug release profile or safety characteristics. By contrast, clinical trials performed by us and others — including a head-to-head clinical trial comparing Xtampza with OxyContin OP — have shown that drug abusers can achieve rapid release and absorption of the active ingredient by manipulating OxyContin OP using common household tools and methods commonly available on the Internet.
In addition, our preclinical studies and clinical trials have shown that the contents of the Xtampza capsule can be removed from the capsule and sprinkled on food, directly into the mouth or administered through feeding tubes, without compromising their drug release profile, safety or abuse-deterrent characteristics. By contrast, OxyContin OP, which is formulated in hard tablets, has a black box warning label stating that crushing, dissolving, or chewing can cause rapid release and absorption of a potentially fatal dose of the active ingredient. We believe that Xtampza, if approved, can address the pain management needs of the approximately 11 million patients in the United States who suffer from chronic pain and have difficulty swallowing.
Since 2010, when we divested our former subsidiary, Onset Therapeutics, LLC, to PreCision Dermatology, Inc., we have devoted substantially all of our resources to the development of our patented DETERx platform technology, the preclinical and clinical advancement of our product candidates, and the creation and protection of related intellectual property. Since 2011, we have not generated any revenue from product sales as we currently have no approved products, and we continue to incur significant research, development and other expenses related to our ongoing operations. Prior to our initial public offering of common stock, or IPO, in May 2015, we funded our operations primarily through the private placement of preferred stock, convertible notes and commercial bank debt.
Outlook
We have never been profitable and have incurred net losses in each year since inception. We incurred net losses of $8.4 million and $7.9 million for the six months ended June 30, 2015 and 2014, respectively. As of June 30, 2015, we had an accumulated deficit of $110.1 million. Substantially all of our net losses resulted from costs incurred in connection with our research and development programs and from general and administrative costs associated with our operations. We expect to continue to incur net losses in the foreseeable future as we seek regulatory approval for, and, if approved, begin to commercialize Xtampza. Our net losses may fluctuate significantly from quarter to quarter and year to year. We expect our expenses will increase substantially in connection with our ongoing activities as we:
· conduct clinical trials of our product candidates;
· continue scale-up and improvement of our manufacturing processes;
· continue our research and development efforts;
· manufacture preclinical study and clinical trial materials;
· maintain, expand and protect our intellectual property portfolio;
· seek regulatory approvals for our product candidates that successfully complete clinical trials;
· hire additional clinical, quality control and technical personnel to conduct our clinical trials;
· hire additional scientific personnel to support our product development efforts;
· implement operational, financial and management systems; and
· hire additional general and administrative personnel to operate as a public company.
If we obtain regulatory approval for Xtampza, we expect to incur significant commercialization expenses related to marketing, manufacturing, distribution, product sales and reimbursement functions. Initially we plan to detail Xtampza to approximately 10,000
physicians who write more than 50% of the branded extended-release oral opioid prescriptions in the United States with a sales team of approximately 100 sales representatives. In addition, we plan to deploy a separate, focused sales team to detail Xtampza to nursing homes, hospices and other institutions treating large populations of the elderly and other patients who need chronic pain relief and have difficulty swallowing. Accordingly, we will seek to fund our operations through public or private equity or debt financings or other sources. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. Our failure to raise capital or enter into such other arrangements when needed would have a negative impact on our financial condition and ability to develop our product candidates.
CRITICAL ACCOUNTING POLICIES AND SIGNIFICANT JUDGMENTS AND ESTIMATES
We believe that several accounting policies are important to understanding our historical and future performance. We refer to these policies as “critical” because these specific areas generally require us to make judgments and estimates about matters that are uncertain at the time we make the estimate, and different estimates—which also would have been reasonable—could have been used, which would have resulted in different financial results.
The critical accounting policies we identified in the Prospectus related to accrued expenses, impairment of long-lived assets, convertible redeemable preferred stock, stock-based compensation and income taxes. There were no changes to these critical accounting policies in the quarter ended June 30, 2015. It is important that the discussion of our operating results that follows be read in conjunction with the critical accounting policies disclosed in the Prospectus.
RESULTS OF OPERATIONS
Comparison of the Six Months ended June 30, 2015 and June 30, 2014
Research and development expenses were $6.8 million for the six months ended June 30, 2014 (the “2014 Period”), compared to $3.1 million for the six months ended June 30, 2015 (the “2015 Period”). The $3.7 million decrease was primarily related to:
· a decrease in clinical trial costs of $4.3 million due to the completion of clinical trials with Xtampza during 2014; and
· an increase in manufacturing costs of $379,000 mainly due to costs incurred for validation batches of Xtampza.
General and administrative expenses were $1.0 million for the 2014 Period compared to $5.1 million for the 2015 Period. The $4.1 million increase was primarily related to:
· an increase in salaries and wages of $1.7 million primarily due to headcount, bonuses and stock compensation expense;
· an increase in professional fees of $823,000 primarily due to audit, accounting and recruitment fees;
· an increase in commercial costs of $457,000 primarily due to consultant costs related to analytics and strategies for commercialization of Xtampza;
· an increase in legal and consulting fees of $536,000 primarily due to costs related to litigation; and
· an increase in insurance costs of $194,000 due to directors’ and officers’ insurance.
Comparison of the Three Months ended June 30, 2015 and June 30, 2014
Research and development expenses were $3.6 million for the quarter ended June 30, 2014 (the “2014 Quarter”), compared to $1.6 million for the quarter ended June 30, 2015 (the “2015 Quarter”). The $2.0 million decrease was primarily related to:
· a decrease in clinical trial costs of $2.1 million due to the completion of clinical trials with Xtampza during 2014; and
· an increase in manufacturing costs of $124,000 mainly due to costs incurred for validation batches of Xtampza.
General and administrative expenses were $523,000 for the 2014 Quarter compared to $2.9 million for the 2015 Quarter. The $2.4 million increase was primarily related to:
· an increase in salaries and wages of $1.2 million primarily due to headcount, bonuses and stock compensation expense;
· an increase in legal and consulting fees of $402,000 primarily due to costs related to litigation;
· an increase in commercial costs of $237,000 primarily due to consultant costs related to analytics and strategies for commercialization of Xtampza;
· an increase in insurance costs of $182,000 due to directors’ and officers’ insurance; and
· an increase in professional fees of $129,000 primarily due to recruitment fees.
LIQUIDITY AND CAPITAL RESOURCES
Sources of liquidity
We have incurred net losses and negative cash flows from operations since inception. Since inception, we have funded our operations primarily through the private placements of our preferred stock, our IPO, convertible notes and commercial bank debt. As of June 30, 2015, we had $112.4 million in cash and cash equivalents.
In March 2015, we issued 41,666,667 shares of Series D convertible preferred stock in exchange for aggregate consideration of $50.0 million, including $45.0 million in cash. In connection with this financing, convertible notes with related parties in the aggregate
principal amount of $5.0 million automatically converted to an aggregate of 4,166,667 shares of Series D convertible preferred stock.
In May 2015, we closed our IPO, which resulted in the sale of 6,670,000 shares of our common stock at a public offering price of $12.00 per share, including 870,000 shares of common stock upon the exercise by the underwriters of their option to purchase additional shares at the public offering price. We received net proceeds from the IPO of approximately $72.0 million, after deducting underwriting discounts, commission and expenses payable by the Company
Although it is difficult to predict future liquidity requirements, we believe that the net proceeds from the IPO, together with our existing cash resources, will be sufficient to fund our operations into mid-2017, including the commercialization of Xtampza, if approved, and the continuation of our development of our other product candidates. We have based this estimate on assumptions that may prove to be incorrect and we could use our available capital resources sooner than we currently expect. We may never become profitable, or if we do, we may not be able to sustain profitability on a recurring basis.
Cash flows
Operating activities. The cash used was $6.1 million in the 2015 Period and $6.0 million in the 2014 Period. The change in both periods was primarily due to the change in net loss partially offset by changes in the working capital accounts. We expect cash used in operating activities to increase for the foreseeable future as we seek regulatory approval for, and, prepare to commercialize Xtampza by establishing sales, marketing, manufacturing and distribution capabilities and fund research, development and clinical activities for additional product candidates.
Investing activities. The cash used in the 2015 Period was related to the purchase of property and equipment. There was no cash used in the 2014 Period.
Financing activities. The cash provided by financing activities for the 2015 Period primarily represent net proceeds from the IPO and from the sale of Series D convertible preferred stock of $72.0 million and $44.8 million, respectively. The cash provided by financing activities for the 2014 Period primarily reflect approximately $1.1 million drawdown of a term note payable.
Funding requirements
Since 2011, we have not generated any product revenue. We do not know when, or if, we will generate any revenue as we seek regulatory approval for, and potentially begin to commercialize, Xtampza. We anticipate that we will continue to incur losses for the next several years, and we expect the losses to increase as we continue the development of, and seek regulatory approvals for, Xtampza and our other product candidates, and begin to commercialize any approved products. We are subject to all of the risks common to the development of new pharmaceutical products, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. We will incur additional costs associated with operating as a public company. We anticipate that we will need substantial additional funding in connection with our continuing operations.
Until we can generate a sufficient amount of revenue from our pharmaceutical products, if ever, we expect to finance future cash needs through public or private equity or debt offerings. Additional capital may not be available on reasonable terms, if at all. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or commercialization of one or more of our product candidates. If we raise additional funds through the issuance of additional debt or equity securities, it could result in dilution to our existing shareholders, increased fixed payment obligations and the existence of securities with rights that may be senior to those of our common stock. If we incur indebtedness, we could become subject to covenants that would restrict our operations and potentially impair our competitiveness, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. Any of these events could significantly harm our business, financial condition and prospects.
Our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement and involves risks and uncertainties, and actual results could vary as a result of a number of factors. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect. The amount and timing of future funding requirements, both near- and long-term, will depend on many factors, including:
· the design, initiation, progress, size, timing, costs and results of preclinical studies and clinical trials for our product candidates;
· the outcome, timing and cost of regulatory approvals by the FDA and comparable foreign regulatory authorities, including the potential for the FDA or comparable foreign regulatory authorities to require that we perform more studies than, or evaluate clinical endpoints other than those that we currently expect;
· the timing and costs associated with manufacturing Xtampza and our other product candidates for clinical trials, preclinical studies and, if approved, for commercial sale;
· the number and characteristics of product candidates that we pursue;
· the cost of patent infringement litigation, including the Company’s litigation with Purdue Pharma, L.P., or Purdue, relating to
Xtampza or our other product candidates, which may be expensive to defend and delay the commercialization of Xtampza or our other product candidates;
· our need to expand our research and development activities, including our need and ability to hire additional employees;
· our need to implement additional infrastructure and internal systems and hire additional employees to operate as a public company;
· the effect of competing technological and market developments; and
· the cost of establishing sales, marketing and distribution capabilities for any products for which we may receive regulatory approval.
If we cannot expand our operations or otherwise capitalize on our business opportunities because we lack sufficient capital, our business, financial condition and results of operations could be materially adversely affected.
CONTRACTUAL OBLIGATIONS
There have been no material changes to the contractual obligations and commitments described under Management’s Discussion and Analysis of Financial Condition and Results of Operations in the Prospectus.
OFF-BALANCE SHEET ARRANGEMENTS
We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined under SEC rules.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
We are exposed to market risk related to changes in interest rates. As of June 30, 2015, we had cash and cash equivalents consisting of cash and money market funds of $112.4 million. Our primary exposure to market risk is interest rate sensitivity, which is affected by changes in the general level of U.S. interest rates, particularly because our money market funds are short-term highly liquid investments. Due to the short-term duration and the low risk profile of our investments, an immediate 10% change in interest rates would not have a material effect on the fair market value of our portfolio.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of June 30, 2015. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of the effectiveness of the design and operation of our disclosure controls and procedures as of June 30, 2015, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
Changes in Internal Control Over Financial Reporting
No change in our internal control over financial reporting occurred during the fiscal quarter ended June 30, 2015 that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.
We filed the NDA for Xtampza as a 505(b)(2) application, which allows us to reference data from an approved drug listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), in this case OxyContin OP. The 505(b)(2) process requires that we certify to the FDA and notify Purdue, as the holder of the NDA and any other Orange Book-listed patent owners, that we do not infringe any of the patents listed for OxyContin OP in the Orange Book, or that the patents are invalid. We made such certification and provided such notice on February 11, 2015 and such certification documented why Xtampza does not infringe any of the 11 Orange Book listed patents for OxyContin OP, five of which stand invalidated by the Federal District Court for the Southern District of New York, subject to a pending appeal. Under the Hatch-Waxman Act of 1984, Purdue had the option to sue us for infringement and receive a stay of up to 30 months before the FDA can issue a final approval for Xtampza,
unless the stay is earlier terminated.
Purdue exercised its option and elected to sue us for infringement in the District of Delaware on March 24, 2015 asserting infringement of three of Purdue’s Orange Book-listed patents (all of which stand invalidated subject to a pending appeal by Purdue) and a non-Orange Book-listed patent, and accordingly, received a stay of up to 30 months before the FDA can issue a final approval for Xtampza, unless the stay is earlier terminated. On March 26, 2015, Purdue filed a second suit against us in the District of Massachusetts asserting infringement of the same four patents.
We have engaged experienced litigation counsel who worked carefully with us to construct a strategy to prevail in such litigation as expeditiously as possible. On April 6, 2015, in the District of Delaware case, we filed a motion to dismiss for lack of personal jurisdiction or, in the alternative, to transfer venue to the Southern District of New York where three of the patents have already been invalidated. On July 23, 2015, Purdue voluntarily dismissed the Massachusetts suit. On August 6, 2015, the Delaware court dismissed the suit in Delaware and issued a memorandum opinion finding the Delaware court lacks personal jurisdiction over the Company Following the dismissal in Delaware, on August 6, 2015, the Company filed a complaint in the Southern District of New York asserting an action to obtain patent certainty, and requesting that the New York court find that Xtampza will not infringe any valid patent claim of the patents asserted by Purdue in the Delaware action. Also on August 6, 2015, Purdue sued the Company in the District of Massachusetts asserting the same claims as the prior suit. On August 7, 2015, Purdue filed a motion in the Delaware court requesting reconsideration of the August 6, 2015 order that dismissed the case. In the motion requesting reconsideration, Purdue asks that the Delaware court find that it does have personal jurisdiction over the Company but transfer the case to the District of Massachusetts. We plan to continue to take all steps necessary to vigorously defend ourselves against these claims.
You should carefully review and consider the information regarding certain factors that could materially affect our business, financial condition or future results. These and other risks are described below and under the heading “Risk Factors” in the Company’s Current Report on Form 8-K filed with the SEC on June 19, 2015.
Our success depends in large part on the success of our lead product candidate, Xtampza. We cannot give any assurance that we will receive regulatory approval for Xtampza, which is necessary before it can be commercialized.
To date, we have invested substantial resources in the development of our lead product candidate, Xtampza, and our business and future success are substantially dependent on our ability to successfully and timely obtain regulatory approval for and commercialize this product candidate, which may never occur. We currently generate no revenues from sales of any drugs and we may never be able to develop or commercialize a marketable drug.
The regulatory approval process that Xtampza must undergo is rigorous, time-consuming and difficult to predict, and there is no guarantee that successful late-stage clinical trials, including the pivotal Phase 3 clinical trial we completed in July 2014, will result in FDA approval of our NDA for Xtampza, which was accepted for filing on February 10, 2015. On February 25, 2015, the FDA set a PDUFA goal date of October 12, 2015 for completion of its review of Xtampza NDA. However, pursuant to FDA guidance, the PDUFA goal date is flexible and subject to change based on the timing and materiality of any amendments to the NDA, the FDA’s existing workload, and other potential review issues. There can be no assurances that the FDA will not extend the PDUFA goal date that has been established for completion of its review of the Xtampza NDA.
The FDA has announced a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (“AADPAC”) and the Drug Safety and Risk Management Advisory Committee (“DSaRM”), to discuss the Xtampza NDA. The meeting is scheduled for September 11, 2015. Part of the meeting will be closed to the public.
An advisory committee typically includes clinicians and other experts who evaluate the NDA and issue a recommendation to the FDA as to whether the application should be approved. The FDA has published its agenda for the meeting in the August 10, 2015, Federal Register Notice. The FDA has asked the committees to discuss the potential safety risks and the potential effects on efficacy associated with the extent of Xtampza’s food effect, and the potential fluctuations in oxycodone levels that may occur if the product is not taken consistently with the same amount of food. In addition, the committees will be asked to review and discuss whether the data characterizing the abuse-deterrent properties support the likelihood that Xtampza will have a meaningful effect on abuse and whether potential benefits to the public from abuse-deterrence outweigh the potential risks to patients from the effect of food.
We cannot predict how the AADPAC and DSaRM will interpret the data and whether they will vote in favor of approval is uncertain. The FDA is also not bound by the recommendations of the advisory committees, and the final decision regarding approval of Xtampza will be made by the FDA. If the advisory committees recommend against approval of our NDA, we may not succeed in securing FDA approval for Xtampza. If the committees vote in favor of approval, the FDA may ultimately decide not to approve our NDA application. Even if the FDA approves Xtampza, matters discussed at the meeting of AADPAC and DSaRM could limit our ability to successfully commercialize Xtampza.
Any delay or impediment in our ability to obtain approval to commercialize Xtampza may cause us to be unable to generate the revenues necessary to continue our research and development pipeline activities, thereby adversely affecting our business and our prospects for future growth.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
RECENT SALES OF UNREGISTERED SECURITIES
None.
USE OF PROCEEDS
Our IPO was effected through a Registration Statement on Form S-1 (File No. 333-203208) that was declared effective by the SEC on May 6, 2015, which registered an aggregate of 6,670,000 shares of our common stock. On May 12, 2015, 6,670,000 shares of common stock were sold on our behalf at an initial public offering price of $12.00 per share, including 870,000 shares of common stock upon the exercise by the underwriters of their option to purchase additional shares at the public offering price, for aggregate gross proceeds of $74.4 million. As of the date of filing this report, the offering has terminated, and all of the securities registered pursuant to the offering have been sold prior to termination. Jefferies LLC and Piper Jaffray & Co. acted as joint book-running managers. Wells Fargo Securities, LLC acted as lead manager and Needham & Company, LLC acted as co-manager in the offering.
The net proceeds of the offering to us, after deducting underwriting discounts and commissions of $5.6 million and offering expenses of $2.4 million, were approximately $72.0 million. On May 12, 2015, the closing date of the offering, we received the proceeds from the offering, $6.6 million of which have been utilized for the development of our commercial infrastructure, research and development of our other product candidates and general corporate purposes, including working capital.
The foregoing expenses are a reasonable estimate of the expenses incurred by us in the offering and do not represent the exact amount of expenses incurred. All of the foregoing expenses were direct or indirect payments to persons other than (i) our directors, officers or any of their associates; (ii) persons owning 10% or more of our common stock; or (iii) our affiliates.
There has been no material change in the use of proceeds from the IPO as described in the Prospectus under “Use of Proceeds”.
PURCHASE OF EQUITY SECURITIES
We did not purchase any of our registered equity securities during the period covered by this Quarterly Report on Form 10-Q.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not Applicable.
Not applicable
The exhibits filed as part of this Quarterly Report on Form 10-Q are set forth on the Exhibit Index, which Exhibit Index is incorporated herein by reference.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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COLLEGIUM PHARMACEUTICAL, INC. | |
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Date: August 12, 2015 |
By: |
/s/ MICHAEL HEFFERNAN |
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Michael Heffernan |
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Chief Executive Officer |
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(Principal executive officer) |
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Date: August 12, 2015 |
By: |
/s/ PAUL BRANNELLY |
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Paul Brannelly |
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Chief Financial Officer |
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(Principal financial and accounting officer) |
EXHIBIT INDEX
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3.1 |
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Second Amended and Restated Articles of Incorporation of Collegium Pharmaceutical, Inc., incorporated by reference to the designated exhibit of the Company’s Current Report on Form 8-K filed on May 12, 2015. |
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3.2 |
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Amended and Restated Bylaws of Collegium Pharmaceutical, Inc., incorporated by reference to the designated exhibit of the Company’s Current Report on Form 8-K filed on May 12, 2015. |
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10.1 |
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Employment Agreement, dated August 4, 2015, by and between Michael Heffernan and Collegium Pharmaceutical, Inc., incorporated by reference to the designated exhibit of the Company’s Current Report on Form 8-K filed on August 10, 2015. |
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10.2 |
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Employment Agreement, dated August 4, 2015, by and between Paul Brannelly and Collegium Pharmaceutical, Inc., incorporated by reference to the designated exhibit of the Company’s Current Report on Form 8-K filed on August 10, 2015. |
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10.3 |
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Employment Agreement, dated August 4, 2015, by and between Barry S. Duke and Collegium Pharmaceutical, Inc. (filed herewith). |
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31.1 |
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Certification of Chief Executive Officer pursuant to Rules 13a- 14(a) or 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed herewith). |
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31.2 |
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Certification of Chief Financial Officer pursuant to Rules 13a- 14(a) or 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed herewith). |
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32.1 |
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Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (furnished herewith). |
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32.2 |
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Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (furnished herewith). |
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101.INS |
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XBRL Instance Document |
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101.SCH |
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XBRL Taxonomy Extension Schema Document |
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101.CAL |
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XBRL Taxonomy Extension Calculation Linkbase Document |
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101.DEF |
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XBRL Taxonomy Extension Definition Linkbase Document |
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101.LAB |
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XBRL Taxonomy Extension Label Linkbase Document |