|Shares Out. (in M):||65||P/E||NA||NA|
|Market Cap (in $M):||97||P/FCF||NA||NA|
|Net Debt (in $M):||-11||EBIT||-75||-55|
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Zogenix, Inc. (ZGNX or the Company) is a specialty pharmaceutical company that has been bombed out on the back of financing overhang, tax loss selling and growth/partnership concerns, leading to a situation where at the current valuation you are buying the existing, marketed product (Sumavel DosePro) at a discount, and you get a clinically de-risked pipeline and a platform technology for free. See the following link for a PDF version of this write-up. http://www.box.com/s/2gz011ox6kroe4bqmbn8
ZGNX was founded in 2006 with the acquisition of needleless injectable technology (DosePro) from Aradigm. ZGNX’s management team has a proven clinical, regulatory, business development and commercialization track record, as well as, significant expertise in central nervous system disorders and pain. Contrary to most biotech/spec pharmas, ZGNX has executed well since the Company’s founding -- ZGNX has successfully:
At September 31, 2011, ZGNX had $70.8 million in cash, $59.6 million in debt, and has a current market capitalization of approximately $90 million. The company trades at a revenue/EV multiple of 1.1x 2012 Consensus/1.5x Pretium 2012 revenue estimates (we’re obviously below the Street but this doesn’t matter at this valuation.)
WHAT HAPPENED TO THIS STOCK?
ZGNX completed its IPO raising $57.7 million in November 2010 at $4/share. The offering came during tough IPO conditions as indicated by the company only filling part of the green shoe. The Company raised less money than they anticipated and has remained under a financing overhang since then. This summer ZGNX raised $30 million through a synthetic royalty debt deal, but at that time, they well telegraphed they’d be raising more equity after they released positive Phase 3 results for Zohydro. On August 17th as the market began blowing up, ZGNX released the positive data and the stock began to fall amidst market conditions and the pending equity raise. Leerink Swann, the lead manager, unfortunately botched the deal. Leerink first announced a 12mm share offering on August 24th ahead of the holiday weekend, and then subsequently pulled the deal. Then on September 2nd they relaunched the deal. Then Leerink substantially increased the size of the deal (5x!) to 60mm shares citing pressure from the big circles in the deal for the Company not to come back to the market. The deal priced @ $2/share; by the time the deal priced, the stock had declined 42% from 8/24.
To be fair, the price decline wasn’t solely due to the liquidity overhang. The growth of ZGNX’s only marketed product, Sumavel, was slowing at that time due to severe issues with the Astellas relationship (more on this below) and anyone watching the prescription trends could see they were going to have to take estimates down, which they did in November when they published 3Q results. That said, in the face of very positive Zohydro efficacy data, a product with $500mm+ sales potential, Leerink’s handling of the offering was not ideal. (As an aside, Leerink also under-delivered on the July PIPE deal for NGSX, diluting the company 50% - a discount that might even cause Rodman & Renshaw to blush.)
As a result of this large placement of shares, Leerink and Wells Fargo’s desks likely took down a large part of the deal as there wasn’t enough demand for that number of shares. In talking with a local rep for WFC, his syndicate asked him if he wanted to take any more shares in the deal – he said this only happens when the desks own a lot of the deal. And so, in addition to anyone wanting to short the stock, you had Leerink and WFC continually selling it as well. Now as we get to year end, ZGNX is stuck in tax loss selling hell despite Sumavel prescription trends reaccelerating and the Company confirming they had a positive end of Phase 3 meeting with the FDA for Zohydro, and confirmed plans to file the NDA in 2012. It is these positive business trends, coupled with an extremely discounted valuation, that we believe will drive the equity higher from here.
Astellas Sumavel Partnership – The Last Overhang Removed
In August 2009, ZGNX and Astellas entered into an exclusive co-promotion agreement for the US. Under the agreement, ZGNX primarily targets the neurology market, while Astellas focuses on primary care (PCP). ZGNX has responsibility for manufacturing and distribution. Astellas paid ZGNX $20 million upfront and receives half of all revenues generated through the PCP route as a ‘service fee’. The agreement was only scheduled to run through 2013 as ZGNX always intended to solely market its products once Zohydro was approved. Given the small investment from Astellas and short duration, one can argue the deal was set up to fail day 1.
Astellas used the Sumavel partnership to launch its PCP sales force in the US. They hired a rent-a-rep sales force to launch the product that ultimately was staffed with inexperienced reps. Not surprisingly, Astellas failed marketing the product despite their 400 person force (vs. ZGNX’s ~80); Astellas only managed to generate approximately 35-40% of the sales. Astellas tried to reorganize their sales force over the summer post reacquiring VESIcare, a PCP product, from GSK and hired the reps internally. This reorganization wreaked havoc on the PCP Sumavel prescription trends (growth went to zero basically in that segment); Astellas completed the realignment in Nov/Dec.
Despite the reorganization, ZGNX announced on 12/21/11 that it had determined Astellas wasn’t a fit and opted out of the agreement . ZGNX will reevaluate its options to further support the product outside of the existing salesforce, which it expanded an additional ~15 reps in September. ZGNX reported in its call announcing the termination that they have received inbound requests from other pharmas to market the product and will be making further announcements about next steps to reach the PCP market in 1Q12. Some were surprised to see this but given that the Astellas agreement was already due to expire in 2013 and how poorly Astellas had actually marketed the product, ZGNX made an NPV positive decision and cut Astellas loose. We think this is a long-term positive for the stock and removes a key overhang.
CATALYSTS – WHY DO WE BUY NOW?
Now that the Astellas news is out of the way and tax loss selling should be coming to a close, the below items should drive the stock in 2012:
Sumavel DosePro is a single-use disposable needle-free injection system that offers a faster-acting and more efficacious treatment alternative to oral, nasal and needle based formulations. Sumavel can provide onset of migraine pain relief in 10 minutes for some patients vs. up to 2 hours+ for orals. In its first 12 months of launch, Sumavel recorded $19 million of sales, growing to ~$36 million in 2011. Sumavel is protected by four Orange Book listed patents, with the last patent expiring in 2025; there is also extensive manufacturing know-how protecting the product.
Sumavel is administered to the abdomen or thigh and can be injected in a quick 3 step process. An illustration can be found at http://sumaveldosepro.com/. This compares to a cumbersome multi-step process with other injectables where you have an exposed needle and complicated preparation/injection to do in the midst of a literally blinding headache.
For those fortunate enough not to know, migraine is a debilitating condition characterized by moderate to severe headaches, and nausea. According to the National Headache Foundation, there are about 28 million migraine sufferers in the US, of which about 50% of those afflicted have been diagnosed, and occurs about three times more often in women than in men. The estimated direct medical expenditures for migraine, including outpatient costs, pharmaceutical costs, inpatient costs and emergency department costs, exceed $11.0 billion per year in the US. Migraine sufferers may experience one to three migraines per month. The cause of migraine headache is unknown; the most common theory is a disorder of the serotonergic control system (abnormally low levels of serotonin).
Triptans as the Acute Migraine Treatment Gold Standard
Triptans are the gold standard for the treatment of acute migraine attacks with approximately 97% of total market prescriptions (scripts). Of the 7 available triptans, sumatriptan (branded and generic) remains the most prescribed triptan despite only slightly varying efficacy amongst them all; injectable delivery has the best in class efficacy data/ pain relief among triptans. As comparison, for the standard migraine endpoint “pain relief after 2 hours”:
Oral and nasal delivery can only achieve pharmacologically sufficient triptan plasma concentrations after 60-90 minutes, resulting in a much slower onset of pain relief vs. the 10 minutes seen with injectables. (Efficacy in this class is determined by time to Tmax, meaning how quickly the drug reaches peak concentration the patient’s bloodstream.)
Sumavel Efficacy Data
ZGNX referenced GSK’s Imitrex injection (Statdose) for efficacy via bioequivalence evidence, complemented by administration site tolerability and patient usability studies, for its approval via the 505(b)(2) pathway. Clinical studies established that Sumavel offers the same high efficacy and immediate relief in a more attractive and easier to use delivery mechanism. In a study of 54 patients, Sumavel’s abdomen or thigh injection was bioequivalent to Imitrex Statdose with same absorption rate and similar safety profile. In a repeat dose and multiple injection safety trial with 18 patients, bioequivalency was established in abdomen and thigh and median T-max were comparable as well as “early exposure” AUCs bioequivalent (see graphs below). Adverse events were mild and transient (immediate bleeding, localized swelling, some bruising), with no patients dropping out and no safety or tolerability concerns.
[see pdf for chart]
Though efficacy is comparable, so are triptan side effects. Due to the rapid spike in drug exposure on injection, atypical sensations and chest discomfort can occur in up to 47% of patients, leading many to avoid utilizing this route. Though potential for uncomfortable treatment side effects remains a limitation, ZGNX has been working to address this perception by ensuring that patient expectation regarding side effect profile and tolerability are properly established. These triptan events are concerning, but transient (only a few minutes). In market studies related to injection, the complexity of administration and needle-phobia were thought to be the bigger hindrances to injectable therapy.
The adverse effects related to Sumavel were application site reactions (swelling, immediate bleeding, localized swelling, pain sensation, delayed occasional bruising), all of which were transient and did not results in patient withdrawals from Sumavel studies. No cumulative effects of multiple doses to a single administration site were observed for any of the local site reactions. Notably, while pain scores related to injection were similar with available injection routes, preference studies widely favored Sumavel in terms of ease of use, convenience, pain and disposal.
Sumavel Launch Curve
[see pdf for chart]
According to ZGNX, 35% of the 7,500 physicians who have prescribed Sumavel had not written for needle-based injectable sumatriptan during 2010, demonstrating appeal of Sumavel beyond traditional users of sumatriptan injection (this means that Sumavel is attracting patients who traditionally have used oral or nasal administered triptans – this is very good for the product.) In addition, the refill rate for Sumavel at the end of June 2010 was 21%, which has grown to 39% in 3Q11 (this is also good). Note that since a typical Sumavel patient refills their prescription only three to four times a year (given the episodic nature of the indication), it is a very good indication of patient satisfaction to see the refill rates where they are only 22 months into launch. At YE 2010, 35% of patients are using Sumavel as part of a dual-therapy treatment program.
Recent Script Trends
Due to issues with the Astellas relationship (sorry, see below), script growth halted during the summer. Sequential growth dropped to 6% in 3Q11 from 24% 2Q11. However, ZGNX has reaccelerated scripts in the 4Q, with scripts growing the first 9 weeks 14-16% sequentially.
In October 2009, Desitin filed for European regulatory approval of Sumavel following the successful completion of a European pivotal bioequivalence trial. Denmark was the first country in the EU to approve Sumavel, on 12/2/10 (the rest achieved through EU decentralized procedure.) Sumavel has no material sales in the EU to date.
Existing Generic Injectable Formulations of Sumatriptan
Generic injectable sumatriptan in the form of vials and prefilled syringes is available from a number of pharmaceutical companies including Par Pharmaceuticals, Sandoz, GSK, PFE/King/US WorldMeds, although these products and alternative autoinjector forms of sumatriptan injection may not be directly substituted for Sumavel (B/X rated to Sumavel.) Presently, ZGNX is seeing little impact from substitution on the uptake of Sumavel.
Despite Existing Treatment Options, an Unmet Medical Need Remains
Leerink conducted a comprehensive survey of 104 PCPs and neurologists with MEDACorp (affiliated physician consultant service) in September 2010 which highlighted the unmet medical need for better migraine treatments. The survey confirmed treatment with oral triptans currently is the first-line option in the acute treatment of moderate-severe migraine attacks, but 30-40% of patients do not respond to first-line oral triptans. Despite poor efficacy, Leerink estimates that roughly 4.7 million patients in the US are currently on oral triptans, providing a large addressable market for Sumavel.
Limitations of Current Treatments for Acute Migraine
Overview of Sumavel Pricing Risks
Sumavel is priced at a discount to Statdose and at a slight premium to generic injectables. Although the migraine market has seen generic entry on both oral and injectable versions of sumatriptan, almost 98% of patients in the top 21 health plans have Sumavel prescription coverage (with some step edits and prior authorizations) and over 75% of prescriptions have been approved at pharmacies to date (according to ZGNX.) Sumavel’s price at launch was $83 per injection. ZGNX has pursued Tier 3 reimbursement with access-improving/couponing programs generating Tier 2-level copays of approximately $15 and easier pre-authorizations. With many managed care negotiations complete, the average net realized price for Sumavel is now ~$72/unit (including copay assistance). According to Wolters Kluwer, generic SQ Imitrex costs $60/vial and Imitrex StatDose refills cost ($180/unit). Nevertheless, a successful reimbursement strategy employed by ZGNX is keeping out-of-pocket costs for end-users low and pricing competitive.
According to management over 80% of patients have been approved at the pharmacy, which bodes well for the physician and patient prior authorization support service with mail-order fulfillment run by the company. Prior authorization has so far been necessary in only ~9% of patients. Lastly, prescription fill rates at the pharmacy are currently approximately 80%, indicating that most patients are not seeing price as an issue.
Competitive Environment Increasingly Favorable for Novel Products
Sumavel competition is limited mainly to triptans and DHE, and sumatriptan is the most widely prescribed pharmaceutical for migraine and is widely available in generic form. Sumavel has the benefit of entering the migraine market at a time when promotion of branded triptans is at an all time low due to the expiration of legacy branded triptan products’ IP (down 70% since 2005). Given the limitations of current options and the continued needs of these patients; however, industry R&D efforts have resulted in several recently approved products and other late stage products. Specialists note that no two headaches are created equal, and the market is becoming increasingly sophisticated in terms of the ability to identify different migraine characteristics in different patients at different times. Each product will most likely serve unique segments of the marketplace.
Overview of Notable Pipeline Competitors
Levadex is an orally inhaled formulation of DHE for acute migraine, which works faster than oral triptans, but not as fast as Sumavel, with similar efficacy to orals (in Phase 3 approximately 58% of patients achieved pain relief in two hours and 36% showing durable relief up to 48 hours.) DHE is a different chemical molecule than triptans, so patients and doctors may consider it after failing one or more triptans. DHE is currently not used frequently because of lack of suitable formulations, its nausea side effect, and a requirement for IV infusion. Levadex’ strongest value proposition is in triptan non-responders since it offers an alternative mechanism of action to triptans. If approved in the convenient “Tempo” inhaler formulation, Levadex should have significant advantages over current formulations of DHE due to the reduced nausea (4.5% for Levadex vs. >60% patients for IV DHE). Leerink Swann projects Levadex peak worldwide sales potential of $540 million; some Street estimates top $1 billion for the product. Levadex’s intellectual property is centered in its delivery device as DHE is generic.
Zelrix is an active, single-use transdermal sumatriptan patch being developed for the treatment of acute migraine. Zelrix may be most frequently used by patients who respond to triptans but are sensitive to side effects or who have significant nausea that precludes their use of orally administered drugs. Zelrix utilizes a patch technology that actively transdermally delivers the drug through the skin using a mild electrical current (iontophoresis.) The patch delivers sumitriptan at a relatively fast rate during the first hour, and then at a slower rate to provide persistent relief throughout the rest of the migraine attack. The method of delivery is intended to improve the consistency of drug effect by avoiding absorption-related issues, to allow treatment of patients with significant nausea, and to minimize triptan-related side effects seen with injectable forms. Onset of pain relief, however, is slower than SQ Imitrex and inhaled Levadex. Leerink Swann projects Zelrix peak sales potential in the U.S. at $360 million in 2023. Similar to Levadex and Sumavel, Zelrix’s intellectual property is centered in its delivery technology. The FDA initially dinged the product this year but the company believes it can answer FDA questions and ultimately get the product approved without additional data.
Below is a chart comparing Imitrex’s efficacy vs. Levadex and Zelrix. Most importantly, note that nothing works as quickly or as well as a SQ injection of sumatriptan.
[see pdf for chart]
ZOHYDRO – IT’S FREE!
Zohydro is basically an extended release Vicodin sans the Tylenol/acetaminophen co-formulation. ZGNX reported positive Phase 3 results treating moderate to severe chronic pain in patients requiring around-the-clock opioid therapy in August. Zohydro is positioned to potentially be the first single-entity, controlled-release formulation of hydrocodone in the US. There is currently no single-entity formulation of hydrocodone, and no controlled release formulation of hydrocodone. Generic sales of immediate-release hydrocodone were $3.1B in '09, half of which was used to treat chronic pain where an IR version containing acetaminophen is not optimal. Based on the market acceptance of Endo Pharmaceuticals Opana ER (extended release oxymorphone) with sales of the franchise topping $380 million in 2011 and growing 30%+, we believe there is a large market opportunity for Zohydro.
Zohydro utilizes Elan Corp’s (ELN) proprietary Spheroidal Oral Drug Absorption System (SODAS) Technology, which serves to enhance the release profile of hydrocodone to provide consistent 12-hour pain relief relative to existing immediate-release combination formulations. The SODAS technology is a validated delivery system having been accepted by regulatory authorities with five products approved and launched in the U.S. since 2002, including once daily oral dosage forms of Avinza (morphine), Ritalin LA, Focalin XR®, and Luvox CR.
Indication and current formulations
Hydrocodone is an orally active narcotic analgesic (pain reliever) and antitussive (cough suppressant). Hydrocodone is available only in combination with other ingredients, and different combination products are prescribed for different uses. Hydrocodone relieves pain by changing the way the brain and nervous system respond to pain. Hydrocodone relieves cough by decreasing activity in the part of the brain that causes coughing. For the US pain market, hydrocodone is sold combined with acetaminophen (Vicodin and Lortab), aspirin (Lortab ASA), and ibuprofen (Vicoprofen).
Current Use of Hydrocodone
Hydrocodone is often referred to as the “starter” opioid, typically because it is viewed by physicians as less potent. Hydrocodone preparations were historically used for the treatment of acute pain indications after surgery or injury, with the acetaminophen or NSAID component addressing the inflammatory component of these conditions. These combinations were thought to be safe at low doses for short periods of time. However, over time, use of the combination has broadened to chronic therapy for more severe pain, with over 50% of immediate release hydrocodone use in these conditions, according to Stifel Nicolaus.
US Pain Market Overview
According to the American Pain Foundation, over 50 million Americans suffer from chronic pain (with over half requiring more than 12 months of therapy), and approximately 25 million experience acute pain each year due to injuries or surgery. There were an estimated 245 million prescriptions ($13 billion market) written for opioid narcotics in 2010, of which approximately 90% fall in the immediate release category. Additionally, approximately a third of patients require opioid rotation, primarily due to lack of efficacy or tolerance to the compound. Hydrocodone is the most prescribed opioid and currently there is no long-acting hydrocodone product on the market.
[see pdf for chart]
Most marketed hydrocodone products contain the analgesic combination ingredient acetaminophen, which if taken in high quantities over time can cause liver toxicity. In June 2009, the FDA organized a joint advisory committee meeting that highlighted the public health problem of liver injury related to the use of acetaminophen in both over-the-counter (OTC) and prescription products.
Limitations of the Current Hydrocodone Offering
At the level of moderate-to-severe chronic pain, there remain a number of opioid market characteristics and hydrocodone limitations, which leave the environment still open for new opioid options.
Based on the acetaminophen toxicity, we believe the FDA very much wants to approve a hydrocodone-only product. Zohydro is the leading pipeline product. Cephalon is also developing CEP-33237, a tamper deterrent formulation that is in Phase 3 development; Zohydro is at least 6 months ahead of CEPH and given the complexity of studies the FDA will require to prove “tamper resistance” it may be a while before CEP-33237 reaches the market. With limited hydrocodone options available at launch and at least six months ahead of its nearest competitors, ZGNX should have relative freedom to find its market niche.
DOSEPRO TECHNOLOGY – IT’S ALSO FREE!
The DosePro technology has had in excess of 10 years and approximately $250 million of R&D and commercialization investment thus far, and is applicable to a wide variety of pharmaceutical preparations. The “killer app” for DosePro is its potential use in biologics. ZGNX is working on a 1mL formulation/device that will allow for needle-free injection of a host of biologics currently delivered sub-q. Since the DosePro platform modifies delivery of FDA-approved molecules, ZGNX can rely on the 505(b)(2) pathway for NDA submission of future clinical candidates, potentially shortening time to market. Last month ZGNX announced it is developing a 1x/mth injectable form of risperdone (see JNJ’s 1x/wk Risperdal Consta with annual sales >$1.5bn and growing) and they have another preclinical candidate. Management also indicated it is in active discussions with a partner for a biologic molecule to be delivered via DosePro.
The chart below illustrates the opportunity for the DosePro platform. The PK curves for both human growth hormone and erythropoietin demonstrate a tight overlap with SQ needle injections. These curves demonstrate the ability for DosePro to enhance, differentiate and/or extend the branded protection/life cylce of injectable therapeutics.
[see pdf for chart]
Based on the valuation of other public pharmaceutical formulation technology companies with early stage pipelines, we believe the DosePro technology is worth at least $50 million (75cts/share). While the list of public comparables below is not exhaustive, it is illustrative of the value of platform formulation technology companies that do not yet have existing material product sales. For the upside view, see Halozyme’s subq injection technology $1bn valuation as a comp.
|Select Formulation Platform Companies|
|$ in mm|
|Antares Pharma||AIS||$191||Transdermal & needless injection reformulation|
|Alexza Pharmaceuticals||ALXA||$54||Inhaled reformulation|
|BioSante Pharmaceuticals||BPAX||$50||Transdermal reformulation|
|Labopharm||DDSS||$30||Extended release oral technology|
|Durect Corp.||DRRX||$101||Extended release & abuse resistant oral technology|
|Flamel Technologies||FLML||$119||Extended release & abuse resistant oral technology|
Roger L. Hawley - Chief Executive Officer. Hawley is one of the co-founders of Zogenix. and has over 22 years of pharmaceutical experience. Most notably, during his tenure at GSK, he launched 3 triptans into the migraine marketplace.
Stephen J. Farr, Ph.D. – President, Chief Operating Officer. Dr. Farr is also one of the cofounders of ZGNX and has 20 years of drug delivery experience. He has been working with the DosePro technology since 2003.
Ann D. Rhoads – Chief Financial Officer. Ms. Rhoads has served as EVP, CFO since March 2010. She largely has a CFO & PE background with over 18 years of financial experience. Notably, she was CFO of a healthcare services company for 9 years, and prior held roles at Sproat Group (VC arm of DLJ), Bain & Company, and Merrill Lynch Capital Partners.
Cynthia Y. Robinson, Ph.D. – Chief Development Officer. Dr. Robinson has served as CDO of Zogenix since April 2008, and brings over 19 years of industry experience, having held positions at InterMune and Elan Pharmaceuticals. At Elan, Dr. Robinson oversaw a portfolio of 14 global development programs from pre-clinical through commercialization, including multiple products in the areas of CNS and pain.
Domain Associates: 15.5%, Clarus Ventures: 14.6%. Fidelity 10%, Scale Venture Partners 8%, Thomas McNerney 5%, Deerfield 2%, SAC & Millenium <1%, Management 2%. In the September offering, Clarus and Domain doubled down, and the CEO and CFO also bought stock. Scale Venture bought in the open market after the deal.
Based on Goldman Sachs’ sales multiple analysis prepared for the fairness opinion presented to Inspire Pharmaceuticals in its sale to Merck earlier this year, the median sales multiple across 21 comparative transactions completed between 2008-2011 was 2.7x; MRK acquired ISPH at 3.3x sales. The table illustrates what Sumavel is potentially worth in an M&A scenario vs. the current $80mm EV.
|$ in mm||2011 Est.||2012 Est.|
|Premium to Current EV||27%||57%||134%|
Note the above does not provide any valuation for Zohydro nor for the DosePro technology.
The company had ~$70 million in cash at 3Q11. The current cash balance should last them at least another 12 months, potentially much longer if they execute on a new Sumavel partnership, Zohydro partnership or a DosePro partnership. The termination of the Astellas partnership will save approx $7-10 million per annum starting in 2Q. Admittedly, this is the primary risk in the name. However, we believe the collateral here is worth substantially more than the debt and there are many upcoming catalysts that will drive the equity from here, such as non-dilutive financings through partnerships.
DISCLOSURE: We and our affiliates are long Zogenix (ZGNX), and may long additional shares or sell some or all of our shares, at any time. We have no obligation to inform anybody of any changes in our views of ZGNX. This is not a recommendation to buy or sell shares.
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